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Last Updated: February 29, 2020

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PREPOPIK Drug Profile


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Which patents cover Prepopik, and when can generic versions of Prepopik launch?

Prepopik is a drug marketed by Ferring Pharms Inc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-one patent family members in twenty-four countries.

The generic ingredient in PREPOPIK is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

US ANDA Litigation and Generic Entry Outlook for Prepopik

Annual sales in 2017 were $13mm indicating the motivation for generic entry (peak sales were $18mm in 2015).

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (citric acid; magnesium oxide; sodium picosulfate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for PREPOPIK
Drug Prices for PREPOPIK

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Drug Sales Revenue Trends for PREPOPIK

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Recent Clinical Trials for PREPOPIK

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ferring PharmaceuticalsPhase 4
The Cleveland ClinicPhase 4
Ferring PharmaceuticalsPhase 3

See all PREPOPIK clinical trials

Recent Litigation for PREPOPIK

Identify potential future generic entrants

District Court Litigation
Case NameDate
Ferring Pharmaceuticals Inc. v. Novel Laboratories, Inc.2017-07-05
Ferring Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.2017-04-19
Ferring Pharmaceuticals Inc. v. Par Pharmaceutical Inc.2015-02-20

See all PREPOPIK litigation

Synonyms for PREPOPIK
Citric acid / magnesium oxide / sodium picosulfate
Citric acid mixture with magnesium oxide and sodium picosulfate
Clenpiq
S900007380
Paragraph IV (Patent) Challenges for PREPOPIK
Tradename Dosage Ingredient NDA Submissiondate
PREPOPIK FOR SOLUTION;ORAL citric acid; magnesium oxide; sodium picosulfate 202535 2014-05-21

US Patents and Regulatory Information for PREPOPIK

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Ferring Pharms Inc PREPOPIK citric acid; magnesium oxide; sodium picosulfate FOR SOLUTION;ORAL 202535-001 Jul 16, 2012 DISCN Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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